A Double Masked, Placebo Controlled, Single Center, Randomized Clinical Trial to Assess the Safety and Efficacy of ADX-629 in Subjects with Mild Asthma Induced by the Bronchial Allergen Challenge (BAC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
Cliantha Research
Mississauga, Ontario, Canada
Number of Subjects With Serious Adverse Events
Safety was assessed through serious adverse event collection.
Time frame: The safety assessment period was Day 1 - Day 7 for each treatment intervention.
Change From Baseline in the Asthma Control Questionnaire
Change from baseline in the asthma control questionnaire, which is seven questions on a seven-point scale (0 = totally controlled, 6 = extremely poorly controlled). The first six questions are answered by the subject. The seventh question, concerning forced expiratory volume in 1 second (FEV1) percentage predicted (0 = \>95% predicted, 6 = \<50% predicted), is completed by clinic staff. The asthma control questionnaire is calculated as the mean of the response to all seven questions, with a higher score being more severe.
Time frame: The efficacy assessment period was Day 1 through Day 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization.
Change From Baseline in Sputum Eosinophils Percentage of Total Leukocytes
Change from baseline in sputum eosinophils percentage of total leukocytes at seven hours post bronchial allergen challenge and 24 hours post bronchial allergen challenge. A reduction in sputum eosinophils percentage demonstrates improvement.
Time frame: The efficacy assessment period was Day 1 through 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization.
Change From Baseline in Sputum Neutrophils Percentage of Total Leukocytes
Change from baseline in sputum neutrophils percentage of total leukocytes at 7 hours post bronchial allergen challenge and 24 hours post bronchial allergen challenge. A reduction in sputum neutrophils percentage demonstrates improvement.
Time frame: The efficacy assessment period was Day 1 through Day 7 for each treatment period. Baseline is defined as the last non-missing assessment prior to randomization.
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